Trial Profile

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 11 Feb 2026

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At a glance

13 Jan 2026 According to a PharmaEssentia Corporation media release, the USFDA has completed it's filing review of the company's BLA and did not identify any issues. This submission is sufficient to proceed with a substantive review for ropeginterferon alfa-2b-njft for the treatment of adult patients with ET. A PDUFA Date of August 30, 2026 has been given. This sBLA is supported by confirmatory evidence from the North American Phase 2b EXCEED-ET trial and results from the global Phase 3 SURPASS-ET trial
12 Jan 2026 Results presented in the PharmaEssentia Media Release.
06 Jan 2025 According to PharmaEssentia media release, company expects to present data from this clinical trial in the second half of 2025.

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